Although the Food and Drug Administration began to implement the fee provisions of the Food Safety Modernization Act on October 1, the agency is still evaluating comments on fees for facility re-inspections and recalls for both large and small businesses. In comments submitted today, IDFA commended FDA for publishing industry guidance in September and noted several areas, such as hourly rates, practical application and assessment of fees, that require further clarification and consideration.
"Our members need to know when they will be subject to re-inspection fees and should have a reasonable idea of the amount they will be assessed," the comments said. "To provide transparency about its plans and answer the numerous questions that have arisen, FDA should issue written guidance about re-inspection fees."
Some of the areas requiring clarification include:
- the specific instances when re-inspections fees will be assessed;
- the activities that will require fee payments;
- an estimate of total fees for typical situations; and
- how disputes over fees will be resolved.
The comments emphasized that all facilities processing Grade A milk and milk products must comply with the Pasteurized Milk Ordinance (PMO) under the National Conference of Interstate Milk Shipments (NCIMS). These facilities are visited quarterly by state inspectors, and FDA has long recognized the states' primary role in these inspections.
"Re-inspection fees under FSMA should not apply for state inspections or re-inspections conducted under this regime, and we request that FDA affirm this in its next guidance document," the comments said.
IDFA also focused on the proposed hourly rates of $224 for domestic work and $325 for foreign facility re-inspections, calling them "unnecessarily high." Noting that FDA's calculations include the costs of indirect labor, such as information technology and administrative support, IDFA asked the agency to set rates that would cover only direct costs of re-inspection. For comparison, IDFA pointed to the U.S. Department of Agriculture's Food Safety and Inspection Service, which charges overtime costs of $53.92 per hour. IDFA also offered several steps that would help FDA control costs and ensure uniform implementation.
In joint comments filed last week, IDFA and the National Milk Producers Federation outlined the burden that these fees could place on small businesses. They asked FDA to align with the Small Business Administration's definition of "small business," a company with 500 or fewer employees, and to offer reduced fees that would encourage these companies to continue to grow and succeed.
"Our small members already are familiar with their qualification under SBA's regulations, but it could be unnecessarily burdensome for them to reassess their eligibility under a different set of parameters established only for purposes of FSMA's re-inspection fees," the joint comments said.
Any fee reductions for these companies, however, should not be offset by increasing fees for larger companies, IDFA and NMPF concluded.
For more information, contact Clay Detlefsen, IDFA vice president of regulatory affairs, at firstname.lastname@example.org.